SUPPLY CHAIN ARTICLES
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![Teamwok-GettyImages-1411776159]( "4 Risk Mitigation Strategies For mRNA Production")
4 Risk Mitigation Strategies For mRNA ProductionPlanning and procuring custom materials needed to manufacture mRNA remains a top concern. This article shares risk mitigation strategies for multi-sourcing, S&OP process, packaging size, and material expiry.
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![protein bio-synthesis GettyImages-1355122387]( "How Can We Move RNA Forward In Our Therapeutics Arsenal?")
How Can We Move RNA Forward In Our Therapeutics Arsenal?RNA technologies, including mRNA therapeutics, have emerged as a promising drug modality. However, they have unique challenges. BioPhorum has dedicated a team to investigate these challenges and this Q&A shares their practical considerations for how to move this field forward.
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![Talimogene laherparepvec vaccine-GettyImages-960686030]( "Addressing Challenges In Serialization For Complex Therapeutics")
Addressing Challenges In Serialization For Complex TherapeuticsThe magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
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![comic art style speech-GettyImages-1342084200]( "“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNA")
“Holy T7 Polymerase, Batman!”: R&D Considerations For More Awe-Inspiring xRNAIt goes without saying we have some pretty ambitious therapeutic goals for linear mRNA and next-gen saRNA and circRNA. However, as my conversation with Koeris explored, we still have a lot of scientific and technical work/innovation ahead of us to make our RNA products “stronger” (in more ways than one).
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![US flag and European union-GettyImages-2226674966]( "Can America's Retreat On mRNA Be Europe's Opportunity?")
Can America's Retreat On mRNA Be Europe's Opportunity?With HHS winding down mRNA vaccine development under BARDA, could Europe seize the opportunity to lead in mRNA innovation? Exploring the policy shift's implications.
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![coronavirus covid-GettyImages-1220020527]( "FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities")
FDA Sets Recommendations For Predicting Dangerous Nitrosamine ImpuritiesThe FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
SUPPLY CHAIN VIDEOS
In this Bioprocess Online Live panel, we discuss the current state of the mRNA supply chain for critical raw materials and manufacturing supplies and where pain points still exist.
Discover how regional manufacturing, risk-aware practices, and agile strategies are reshaping supply chains to deliver resilience, transparency, and sustainability in today’s complex global environment.
Explore the broad benefits and challenges that could be encounter by working with self-amplifying and circular RNA modalities — particularly in terms of manufacturing, raw material supply, COGS, and patient centricity.
In this Advancing RNA Live clip, CMC consultant Sujit Jain unpacks the levels of maturity he’s observed in process and analytical development, as well as supply chain. While vaccines and liver-targeting therapeutics boast what we can call a reproducible platform today, targeted LNP therapies introduce a handful of scale-up sensitivities and characterization hurdles.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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![GettyImages-1459917555-lab-research-development-gene-genetic]( "Mastering mRNA Manufacturing: A Focus on Raw Materials & Supply Assurance")
Rapid advancements in mRNA-based therapeutic development have underscored the role of raw material quality and supply chain management in ensuring their successful production.
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![iStock-1087219198-lab-computer-cleanroom-research-development-production]( "GMP-Source® And Phase-Appropriate Use For Early-Stage Clinical Trials")
GMP-Source is a more robust, less rigid alternative to full cGMP production that mirrors nearly all of the oversight and quality standards of full cGMP production while relaxing certain commercial standards, helping companies overcome the hurdles that can stall early development.
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![GettyImages-1409734937 RNA polymerase]( "RNA Polymerases For Efficient mRNA Manufacturing")
Precise enzyme selection in IVT reduces dsRNA byproducts and boosts capping efficiency. This ensures high-quality mRNA production while easing the burden of complex downstream purification processes.
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![GettyImages-1284041821 asian vaccine]( "Revolutionizing Patient-Centric Supply Chains To Improve Vaccine Access")
Transparent collaboration and innovation are essential to establishing an infrastructure that supports more agile business models and empowers widespread vaccine access.
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![clinical-trial-manager-shakes-hand-1358280580]( "The Source Of GMP- How Client Demand Drives Innovation")
GMP-Source, which is a term we coined, serves the purpose as a highly qualified raw material for a generation of virus, messenger RNA template, and transgenic expression of proteins.
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![Integrating Genetic Medicine Into Clinical Care]( "Optimization Of Transient Transfection Of MSCs With Plasmid DNA Or mRNA")
Read through the results of our efforts to produce an optimal protocol for the transient transfection of hMSCs with pDNA or mRNA using non-viral means.
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![deep freezing cryopreservation GettyImages-952307842]( "Pioneering The Future Of Pharmaceutical Supply Chains")
Drive the efficiency and resiliency of supply chains by integrating automation, AI, and effective communication, ensuring the successful distribution of lifesaving medicinal products.
